FDA 510(k) Application Details - K012304

Device Classification Name Stethoscope, Electronic

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510(K) Number K012304
Device Name Stethoscope, Electronic
Applicant AMERICAN DIAGNOSTIC CORP.
55 COMMERCE DR.
HAUPPAUGE, NY 11788 US
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Contact MARC BLITSTEIN
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 07/20/2001
Decision Date 11/01/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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